FDA approved zoster vaccine recombinant, adjuvanted, under the trade name Shingrix (GlaxoSmithKline) for prevention of herpes zoster (shingles) in adults aged 50 years and older. The nonlive, recombinant subunit vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01B, developed specifically to overcome the age-related decline in immunity. It is given intramuscularly in two doses of 0.5 mL at month 0 and any time between 2 and 6 months later.
While CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend Shringrix vaccine, also known as herpes zoster subunit (HZ/su), for preferred use over the Zostavax (Merck) vaccine, also known as zoster vaccine live (ZVL), this vote at its October meeting was 8 to 7 in favor, as reported in Pharmacy Today.1
“There was a difference of opinion regarding a preferential recommendation,” said Stephan L. Foster, PharmD, FAPhA, APhA liaison to CDC’s ACIP. “Some voting members felt that a preferential recommendation should have waited until the vaccine has been in clinical use for a while.”
As an advisory committee, ACIP makes recommendations that aren’t official until accepted by CDC and published in CDC’s Morbidity and Mortality Weekly Report. In October, ACIP also voted to recommend HZ/su for adults aged 50 years and older and to recommend revaccination with HZ/su for those previously vaccinated with ZVL.
In the United States, nearly one out of every three people will develop HZ in their lifetime, and an estimated 1 million cases of shingles occur each year, according to CDC.2 About one-half of all cases occur in people aged 60 years or older.
Clinical trial data
The risk of developing HZ increases with age and appears to be related to a decline in Varicella zoster virus (VZV)–specific immunity. In a comprehensive Phase III clinical trial that included more than 38,000 people, Shingrix was shown to boost VZV-specific immune response—demonstrating efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of 4 years.
By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia, a form of chronic nerve pain and the most common complication associated with shingles.